A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment

Blepharitis Clinical Trial

Official title:

A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400511
• Other study ID #: PCLS-OMZ-3001
• Status: Recruiting
• Phase: Phase 3
• Start date: April 22, 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Viatris Inc.
• Contact: Marian Macsai, MD
• Phone: 312-259-2477
• Email: marian.macsai[@]viatris.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Description:

The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects aged = 2 years of age or older at Visit 1, with a diagnosis of blepharitis confirmed by the investigator.

2. Subjects under 18 must able to be examined at the slit lamp (handheld) without systemic anesthesia.

3. A self-reported history of at least 1 previous episode of blepharitis.

4. Adult subjects have provided verbal and written informed consent. For subjects under 16 years of age, a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child's assent should also be sought before inclusion into the study.

5. Subjects who have not responded adequately to lid hygiene in the past (self-reported).

6. Have a Corrected Distance Visual Acuity (CDVA) greater than or equal to 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Subjects may be refracted if needed.

7. Subjects must be able to comply with the requirements of the protocol including the ability to self-administer or receive topical treatment twice a day to their eyelid margins.

8. Be literate and able to complete questionnaires independently, or in the case of pediatric patients, can comprehend the questionnaires with the help of a parent/guardian or interviewer.

9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Visit 1 and must be willing to use an adequate method of contraception throughout the study and 30 days from the last application of the study treatment.

Exclusion Criteria:

1. Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit.

2. Subjects with a history of, or active herpetic or neurotrophic keratitis.

3. Subjects who, in the opinion of the investigator, have abnormal eyelid anatomy (other than due to blepharitis) that might adversely affect clinical signs and symptoms, including but not limited to lagophthalmos, malposition of the eyelid or tumor(s) of the eyelid or eyelid margin.

4. Subjects who have received other treatments for blepharitis within 30 days of Visit 1.

5. Subjects with known hypersensitivity to study medications, or to any diagnostic agents to be used in the study.

6. Subjects who are currently enrolled in an investigational drug or device study or have used an investigational drug or device within the 30 days prior to the baseline visit and during the treatment period.

7. Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol.

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Pimecrolimus 0.3% Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
• Placebo Ophthalmic Ointment
Placebo will be applied twice a day to both eyelid margins.

Locations

Country	Name	City	State
United States	Clinical Investigator Site	Glendale	California
United States	Clinical Investigator Site	Medina	Minnesota
United States	Clinical Investigator Site	Newport Beach	California
United States	Clinical Investigator Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Famy Life Sciences, a Viatris Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eyelid Swelling	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid swelling. A higher score indicates a worse outcome.	6 weeks
Other	Eyelid Redness	Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.	6 weeks
Other	Eyelid Meibomian Gland Plugging	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid meibomian gland plugging. A higher score indicates a worse outcome.	6 weeks
Other	Eyelid Swelling	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid swelling. A higher score indicates a worse outcome.	12 weeks
Other	Eyelid Redness	Complete resolution (score =0 on grading scale 0-4) and change from baseline for eyelid redness. A higher score indicates a worse outcome.	12 weeks
Other	Eyelid Meibomian Gland Plugging	Complete resolution (score =0 on grading scale 0-4) and change from baseline eyelid meibomian gland plugging. A higher score indicates a worse outcome.	12 weeks
Primary	Efficacy of Study Drug	Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome.	6 weeks
Secondary	Ocular Discomfort Score	Change from baseline on ocular discomfort score visual analogue scale on a scale from 0-100 scale where 100 indicates maximum discomfort. A higher score indicates a worse outcome	6 weeks
Secondary	Eyelid Debris	Complete resolution (score-0 on grading scale of 0-4) for eyelid debris. A higher score indicates a worse outcome.	12 weeks
Secondary	Ocular Discomfort Score	Change from baseline on ocular discomfort score visual analogue scale on a scale from 0-100 scale where 0 indicates no discomfort and 100 indicates maximum discomfort. A higher score indicates a worse outcome.	12 weeks